Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
Reported: March 18, 2020 Initiated: November 13, 2019 #D-1004-2020
Product Description
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Details
- Recalling Firm
- Precision Dose Inc.
- Units Affected
- 224,940 unit dose cups
- Distribution
- Nationwide USA
- Location
- South Beloit, IL
Frequently Asked Questions
What product was recalled? ▼
Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080. Recalled by Precision Dose Inc.. Units affected: 224,940 unit dose cups.
Why was this product recalled? ▼
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 18, 2020. Severity: Moderate. Recall number: D-1004-2020.
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